[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"renal-anemia-of-chronic-kidney-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:renal-anemia-of-chronic-kidney-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100603459","a-study-of-pegmolesatide-of-in-dialysis-chronic-kidney-disease-ckd-patients-with-anemia-treated-with-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitor-hif-phi-100603459",false,"NCT07136792","A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)","Efficacy and Safety of Pegmolesatide in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI): a Multi-center, Prospective, Open-label, Randomized Parallel Controlled Trial","Inclusion Criteria:\n\n1. Age between 18-75 years, regardless of gender;\n2. Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg\u002Fm²;\n3. Diagnosis of chronic renal failure, and having undergone a stable regimen of peritoneal dialysis or hemodialysis for at least 12 weeks prior to enrollment (with stable hemofiltration at a frequency of every 2 or 4 weeks if applicable). Stable dialysis frequency and no plans to change the dialysis modality during the trial;\n4. An up to standard dialysis adequacy testing result before randomization: spKt\u002FV ≥ 1.2 for hemodialysis, Kt\u002FV ≥ 1.7 for peritoneal dialysis;\n5. Roxadustat dose ≤ 360 mg\u002Fweek within 4 weeks before randomization, with stable dose; \\[Stable dose is defined as: (the maximum weekly dose within 4 weeks before randomization - the average weekly dose within 4 weeks before randomization) ÷ the maximum weekly dose within 4 weeks before randomization ≤ 30%\\];\n6. Two pre-dialysis HB test values within 4 weeks before randomization of 8.0 - 12.0 g\u002Fdl, with an absolute difference between the two Hb values ≤ 1.3 g\u002Fdl, and an interval of ≥ 7 days between the two HB tests;\n7. Serum ferritin level ≥ 100 μg\u002FL and transferrin saturation (TAST) ≥ 20% at the time of testing before randomization, serum folate ≥ the lower limit of normal, and vitamin B12 ≥ the lower limit of normal;\n8. Understanding of the study procedures and voluntary signing of the written informed consent form.\n\nExclusion Criteria:\n\n1. Known autoimmune diseases, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulation disorders), or other causes of anemia apart from CKD (such as gastrointestinal bleeding or hookworm disease).\n2. Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment.\n3. Known allergy to iron agents or polyethylene glycol molecules.\n4. Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization.\n5. Underwent red blood cell or whole blood transfusion within 12 weeks prior to randomization.\n6. Poorly controlled blood pressure (uncontrolled hypertension is defined as: during the screening period, systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg in two or more blood pressure measurements, or although the blood pressure values are below the aforementioned criteria, the investigator deems it necessary to adjust antihypertensive medications).\n7. Active hepatitis or any of the following abnormal test results during the screening period (ALT ≥ 2 times the upper limit of normal, AST ≥ 2 times the upper limit of normal, DBIL ≥ 2 times the upper limit of normal, serum albumin \\\u003C 2.5 g\u002Fdl).\n8. Participants judged by the investigator to have uncontrolled or symptomatic secondary hyperparathyroidism, or those with blood iPTH \\> 800 pg\u002FmL during the screening period.\n9. C-reactive protein ≥ 30 mg\u002FL during the screening period.\n10. Cardiac function assessed as NYHA Class III or IV during the screening period.\n11. Pregnant or breastfeeding women, or those planning to become pregnant during the study period.\n12. Participants who plan to undergo kidney transplantation during the trial period or have already been kidney donors, or those who plan to undergo elective surgery during the trial period.\n13. Participants deemed by the investigator to have any other factors that make them unsuitable for participation in this trial.",true,"ALL","18 Years","75 Years",{"count":21,"type":22},96,"ESTIMATED","INTERVENTIONAL",[25],"NA","For patients with renal anemia treated with hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), there is a clinical need of switching to long-acting and safe medications.\n\nPegmolesatide, a polyethylene glycol (PEG)-conjugated erythropoiesis-stimulating peptide, is a long-acting erythropoiesis-stimulating agent (ESA) with sustained activity. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. Phase III clinical trials have demonstrated its efficacy and safety in dialysis patients with renal anemia who were previously treated with recombinant human erythropoietin (rHuEPO). However, there are currently no data regarding the efficacy and safety of switching from HIF-PHIs to pegmolesatide, and there is a lack of standard for the dose conversion.\n\nThis study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial, planning to enroll 96 patients.\n\nAll enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.",[28],"Renal Anemia of Chronic Kidney Disease",[30],"Renal Anemia","RECRUITING","2026-01-13",{"date":34,"type":35},"2026-01-15","ACTUAL",{"date":37,"type":35},"2025-09-08",{"date":39,"type":22},"2027-12",{"name":41,"class":42},"Guangdong Provincial People's Hospital","OTHER",24,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100596415","phase-4-pegmolesatide-treatment-for-anemia-in-patients-undergoing-long-term-dialysis-100596415","NCT07045155","Pegmolesatide Treatment for Anemia in Patients Undergoing Long-term Dialysis","Pegmolesatide for Anemia Treatment：Investigation Upgrade Therapy in rhuEPO Patients Undergoing Dialysis: A Prospective, Multicenter, Parallel-Group, Controlled, Open-Label Study（PANGU-stepup）","PANGU-stepup","Inclusion Criteria:\n\n1. Aged ≥18 years and ≤80 years, with no restrictions on gender.\n2. Body weight ≥40 kg and body mass index (BMI) ≥18 kg\u002Fm².\n3. Subjects who have received hemodialysis or peritoneal dialysis for ≥3 months prior to enrollment;\n4. Subjects who have been receiving erythropoiesis-stimulating agents (ESAs) for ≥4 weeks prior to randomization, with an average weekly dose \\>6000 IU in the last 4 weeks (equivalent dose converted to short-acting EPO \\>6000 IU, calculated as the total amount of short-acting EPO used in the last 4 weeks divided by 4);\n5. The most recent Hb value during the screening period and the average Hb value between screening and baseline visits must be ≥70 to \\\u003C110 g\u002FL;\n6. Hemodialysis patients with serum ferritin levels ≥200 μg\u002FL; peritoneal dialysis patients with serum ferritin levels ≥100 μg\u002FL, and the investigator determines that renal transplant is not required during the trial;\n7. Understanding the study procedures and voluntarily signing the Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Known to have active malignancy, polycystic kidney disease, hematologic disorders (including congenital and acquired anemias such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndromes, hemolytic anemia, and coagulation disorders), or other causes of anemia (such as gastrointestinal bleeding or hookworm disease);\n2. Known to have experienced stroke, transient ischemic attack, myocardial infarction, thromboembolic events (deep vein thrombosis), pulmonary embolism, or other serious cardiopulmonary diseases within the past 6 months;\n3. Received anabolic steroid (e.g., androgen) therapy within 12 weeks prior to randomization;\n4. Known to have received red blood cell or whole blood transfusion within 12 weeks prior to the study.\n5. History of significant infection within 4 weeks before randomization as determined by the investigator.\n6. Confirmed blood pressure measurements at rest and in a conscious state using standard measurement methods, with at least three non-consecutive day readings reaching or exceeding systolic blood pressure (SBP) ≥180 mmHg and\u002For diastolic blood pressure (DBP) ≥110 mmHg within 4 weeks before enrollment, or changes in antihypertensive medication treatment. The primary basis for judgment is clinic-measured blood pressure values, but \"white coat hypertension\" should be excluded.\n7. Known allergy to iron agents or polyethylene glycol.\n8. Pregnant or breastfeeding women, women of childbearing age with a positive blood β-HCG test result before the trial, or those planning to become pregnant during the study period.\n9. Scheduled for elective surgery during the trial period.\n10. Presence of any other factors that the investigator deems unsuitable for participation in this trial.","80 Years",{"count":54,"type":22},240,[56],"PHASE4","This study is a prospective, multicenter, parallel-controlled, open-label clinical trial, planned to be conducted across multiple research centers in various provinces and cities in China.\n\nIt will enroll 240 dialysis-dependent chronic kidney disease (DD-CKD) patients with anemia who have been receiving rHuEPO treatment for at least 4 weeks, with hemoglobin (Hb) levels of ≥70 g\u002FL and \\\u003C110 g\u002FL. After enrollment, participants will be randomly assigned in a 1:1:1 ratio to the experimental group, control group, and exploratory group. The study will involve a 24-week treatment and observation period, divided into three phases: a screening period (Day -28 to Day -1), a treatment period (Week 0 to Week 16), and an extension period (Week 17 to Week 24).\n\nThe primary objective is to assess the impact of the three treatment regimens on the hemoglobin levels of patients with DD-CKD anemia.",[59,60,28,61,62],"Dialysis; Complications","Chronic Kidney Disease 5D","Renal Anaemia","Renal Anemia, Chronic",[64,65,66,67,68],"recombinant human erythropoietin","erythropoietin mimetic peptides","Pegmolesatide","Dialysis","renal anemia",{"date":70,"type":35},"2025-09-12",{"date":72,"type":35},"2025-08-01",{"date":74,"type":22},"2028-12-30",{"name":76,"class":42},"Chinese PLA General Hospital",1]